CLEVER CHOICE VOICE+ BLOOD GLUCOSE MONITORING SYSTEM

K102049 · Taidoc Technology Corporation · NBW · May 27, 2011 · Clinical Chemistry

Device Facts

• Record ID: K102049
• Device Name: CLEVER CHOICE VOICE+ BLOOD GLUCOSE MONITORING SYSTEM
• Applicant: Taidoc Technology Corporation
• Product Code: NBW · Clinical Chemistry
• Decision Date: May 27, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Clever Choice Voice + Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and the following alternative sites: the palm, the forearm, the upper-arm, the calf and the thigh. It is intended for use by people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates. The alternative site testing in this system can be used only during steady-state blood glucose conditions. The Clever Choice Voice + Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. This system contains a speaking functionality which provides step by step instructions to aid visually impaired persons.

Device Story

System measures glucose in fresh capillary whole blood via electrochemical biosensor (glucose oxidase). User applies blood sample to test strip; meter processes signal to display glucose concentration. Designed for home use by single patient; includes speaking functionality for visually impaired. Modifications from predicate include updated outer casing, English-language audio output, and selectable measurement units (mg/dL or mmol/L). Output aids patient in monitoring diabetes control effectiveness.

Clinical Evidence

Bench testing only. Validation included cleaning/disinfection efficacy testing using Micro-Kill+ towels (EPA #59894-10-37549) demonstrating complete inactivation of live virus. Durability testing confirmed no change in performance or external materials after 5000 cleaning/disinfection cycles.

Technological Characteristics

Electrochemical biosensor using glucose oxidase. System includes meter, test strips, and control solutions. Features audio output for visually impaired. Supports mg/dL and mmol/L units. Software-controlled measurement and voice guidance.

Indications for Use

Indicated for single patient use for blood glucose monitoring.

Regulatory Classification

Identification

A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

Special Controls

*Classification.* Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Predicate Devices

• FORA V20 Blood Glucose Monitoring System (k100406)

Submission Summary (Full Text)

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## Attachment C2

## 510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.

The Assigned 510(k) number is: k102049

- l . Submitter's Identification: TaiDoc Technology Corporation 3F, 5F, No.127, Wugong 2nd Rd., Wugu Township, Taipei County, 248, Taiwan
Correspondent: Teling Hsu Regulatory Affairs Specialist Tcl: [phone] #1176 Fax: [phone] Email: teling.hsu(@taidoc.com.tw

Prepared date: July 21, 2010

- 2. Device name:
Proprietary name: Clever Choice + Blood Glucose Monitoring System, model . TD-4248

Regulatory information:

- Regulation section: 21 CFR 862.1345 Glucose Test System A.
- B. Classification: Class II
- CGA, Glucose Oxidase, Glucose C. Product Code: NBW, System, Test, Blood Glucose, Over The Counter D. Panel: Clinical Chemistry (75)

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#### 3. Intended Use:

The Clever Choice Voice + Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and the following alternative sites: the palm, the forearm, the upper-arm, the calf and the thigh. It is intended for use by people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates. The alternative site testing in this system can be used only during steady-state blood glucose conditions.

The Clever Choice Voice + Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.

This system contains a speaking functionality which provides step by step instructions to aid visually impaired persons.

- 4. Device Description:
The system consists of three main products: the meter, test strips, and control solutions. These products have been designed, tested, and proven to work together as a system to produce accurate blood glucose test results. Use only Clever Choice Voice+ Test Strips with the Clever Choice Voice + Blood Glucose Monitoring System.

- 5. Substantial Equivalence Information:
- Predicate device name: FORA V20 Blood Glucose Monitoring System A.
- Predicate K number: K100406 B.
- C. Comparison with predicate:

The modified Clever Choice Voice + Blood Glucose Monitoring System has the following similarities to the predicate device:

- same operating principle, ■
- same fundamental scientific technology,
- incorporate the same basic circuit design, 트
- incorporate the same materials, 트
- same shelf life

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- packaged using the same materials, and ■
- manufactured by the same process.

The modifications encompass:

- Meter outer casing design change, such as color and printing, ■
- Software modification of language spoken by meter only in English, l
- Software modification of selectable blood glucose measurement unit i (mg/dL or mmol/L) and use mg/dL as the preset unit.
- 6. Test Principle:

The detection and measurement of glucose in blood is by an electrochemical biosensor technology using glucose oxidase.

- 7. Performance Characteristics:
Clever Choice Voice + Blood Glucose Monitoring System has the same performance characteristics as the predicate device.

A comparison of system accuracy performance demonstrated that the Clever Choice Voice + Blood Glucose Monitoring System and the FORA V20 Blood Glucose Monitoring System are substantially equivalent.

Software verification and validation testing confirmed that the performance, safety and effectiveness of the Clever Choice + Blood Glucose Monitoring System are equivalent to the predicate device.

- 8. Conclusion:
Based on the information provided in this submission, the Clever Choice Voice + Blood Glucose Monitoring System is substantially equivalent to the predicate FORA V20 Blood Glucose Monitoring System.

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Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002

MAY 2 7 2011

TaiDoc Technology Corporation c/o Teling Hsu 3F, 5F No.127, Wugong 2nd Road, Wugu Township Taipei County China (Taiwan) 24888

Re: k102049

Trade/Device Name: Clever Choice Voice+ Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Code: NBW, CGA Dated: February 25, 2011 Received: May 16, 2011

Dear Ms. Hsu

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

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If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its tolli-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

G.C.

Courtney Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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### Attachment C1

# Indications for Use

510(k) Number (if known): k102049

Device Name:

Clever Choice Voice + Blood Glucose Monitoring System, model TD-4248

Indications for Use:

The Clever Choice Voice + Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and the following alternative sites: the palm, the forearm, the upper-arm, the calf and the thigh. It is intended for use by people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates. The alternative site testing in this system can be used only during steady-state blood glucose conditions.

The Clever Choice Voice+ Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.

This system contains a speaking functionality which provides step by step instructions to aid visually impaired persons.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

Over-The-Counter Use __ X (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

Signature

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) KIOZO49

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